MEDICAL COUNTER MEASURES

5.1 Summary

In the event of a major disaster or emergency, critical medical supplies will be needed across the District of Columbia (the District). These items, often referred to as medical countermeasures (MCM), may come from many sources, including District stockpiles, hospital and health system stockpiles, privately owned stockpiles, neighboring jurisdictions through mutual aid, and federal stockpiles. MCM include both pharmaceutical interventions, such as vaccines, antimicrobials, antidotes, and antitoxins, and non-pharmaceutical interventions, such as ventilators, diagnostics, personal protective equipment (PPE), and patient decontamination that may be used to prevent, mitigate, or treat the adverse health effects of an intentional, accidental or naturally occurring public health emergency. A terrorist attack employing biological or chemical weapons may cause mass casualties that require rapid distribution and dispensing of MCM to minimize morbidity and mortality. Similarly, disease outbreaks and natural disasters such as flooding may cause serious health impacts for entire populations that require MCM to mitigate impacts. The Mayor of the District of Columbia's (the Mayor) authority to declare a public emergency and subsequent public health emergency, as well as federal laws, authorize or guide the use of MCM, including liability exemptions in the use of MCM.

5.2 Mayor’s Authority

The Mayor of the District of Columbia (the Mayor) has the authority to declare a state of public emergency (D.C. Official Code § 7-2304) and a subsequent state of public health emergency (D.C. Official Code § 7-2304.01). See section 4.2. In both of these situations, the Mayor’s declaration could implement a wide range of measures designed to respond to and mitigate the emergency, including the deployment of medical countermeasures (MCM). For example, the terms of the declaration could include a temporary overriding of District of Columbia (District) law so as to establish a grant of authority to the Director of the Department of Health (DC Health Director) (or the District’s Chief Health Officer or Chief Medical Officer, or a similarly qualified official) to issue one or more “standing medical orders” or “blanket prescriptions” to enable the distribution, dispensing, and administration of prophylactic medications and/or other pharmaceuticals as a means of combating the emergency and protecting potentially exposed individuals.

5.3 Strategic National Stockpile

The Strategic National Stockpile (SNS), which includes drugs, vaccines, biological products, medical devices, and other supplies, is maintained by the Secretary of the United States Department of Health and Human Services (HHS Secretary) to provide for the emergency health security of the United States. The HHS Secretary may deploy the SNS to respond to an actual or potential public health emergency or to otherwise protect the public health or safety, or as required by the Secretary of the United States Department of Homeland Security (DHS Secretary) to respond to an actual or potential emergency. The federal government established the SNS, which is managed by the Centers for Disease Control and Prevention (CDC), to augment local supplies of critical medical items. See42 U.S.C. § 247d-6b.

One component included in the SNS is “Push Packs”, which are caches of large quantities of medicines, antidotes, and medical supplies that are responsive to a wide range of threats. Push Packs include MCM that may be useful in biological attacks (using agents such as anthrax, plague, and tularemia), nuclear attacks, radiological events, and explosive events, as well as natural disasters and other human caused incidents.

CHEMPACKS are a component of the SNS that are prepositioned and stored locally to provide chemoprophylaxis to nerve agents released during a large-scale chemical event. Having these items forward deployed allows them to be used to treat suspected or confirmed victims immediately. This is essential since any delay in treatment could gravely affect patient outcomes.

5.4 Chemical, Biological, Radioactive, Nuclear, or Explosive Event

Human casualties are the highest priority for emergency responders in natural disasters and human-caused disasters or emergencies, especially acts of terrorism involving Chemical, Biological, Radioactive, Nuclear, or Explosive (CBRNE) weapons. A terrorist attack may be localized or widespread and multiple CBRNE events may occur simultaneously over a short span of time, or in combination with another hazard. The effects may be immediate (chemical agents) or delayed (biological agents). Persons who are not symptomatic but are known or believed to have been exposed will receive MCM as prophylaxis in accordance with the District’s emergency medical plans.

For example, the order may include a provision to expand the types of heath care providers authorized to dispense medications.

The Mayor’s authority in this regard may be delegated to the Chief Public Health Officer/DC Health Director.

5.6 Procurement or Taking of Private Property

The Mayor has the authority, as part of a public health emergency order, to procure property, supplies, and equipment as necessary to respond to the emergency. D.C. Official Code § 7-2304(b).

The District’s procurement laws and regulations provide procedures for emergency procurements when there is an imminent threat to the public health, welfare, property, or safety, or to minimize disruption in District services when an emergency condition exists. SeeD.C. Official Code § 2-354.05; 27 DCMR § 1702.

5.7 Liability Protection

The Mayor has the authority, as part of a public health emergency order, to appoint health care providers as agents of the District, and to specifically exempt healthcare providers from civil liability. D.C. Official Code § 7-2304.01(d)(2), (d)(3).

The Advanced Life Support Act of 1977 (D.C. Official Code § 7-401et seq.) provides for a blanket exemption from civil liability for any person who renders medical care in good faith in an emergency situation on a volunteer basis. This law limits liability for rendering medical care or assistance during any emergency event with or without a public health emergency order. It protects any non-licensed individual rendering emergency care as a Good Samaritan. This law also covers any emergency medical technician (paramedic, intermediate or basic) certified in any state or the District who is providing assistance under the direction of a licensed physician, as well as the licensed physician who is providing the emergency medical instruction as long as the care is provided in good faith and does not constitute gross negligence. During a declared emergency pursuant to D.C. Official Code § 7-2304, this protection is also extended to the employer of the emergency medical technician, provided that the care is rendered in good faith and does not constitute gross negligence.

The Public Readiness and Emergency Preparedness (PREP) Act of 2005 Pub. L. No. 109-148; 42 U.S.C. §§ 247d-6d, 247d-6e authorizes the HHS Secretary to issue a declaration that provides immunity from tort liability for claims of loss (except willful misconduct) caused by, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats, and conditions determined by the HHS Secretary to constitute a present, or credible risk of a future public health emergency, including an Emergency Use Authorization (EUA). The immunity applies to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures, as well as products or technology intended to enhance medical countermeasures. The HHS Secretary's declaration includes, among other things:

The countermeasures covered by the declaration;

The category of diseases, health conditions, or health threats for which administration and use of the countermeasures are recommended;

The effective time period of the declaration;

The population of individuals receiving the countermeasure;

Limitations, if any, on the geographic area for which immunity is in effect;

Limitations, if any, on the means of distribution of the countermeasure; and

Any additional persons identified by the HHS Secretary as qualified to prescribe, dispense, or administer the countermeasures.

The PREP Act also authorizes a fund in the United States Treasury to provide compensation for injuries directly caused by administration or use of countermeasures covered by the Secretary's declaration.

An EUA permits the use of an unapproved drug, device, or biological product, or an unapproved use of an approved drug, device, or biological product once a determination has been made by the HHS Secretary that sufficient justification exists based on an actual or potential public health emergency. The authority for an EUA is pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3et seq.